5.4 Planning

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet applicable regulatory requirements and requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality management system planning

Top management shall ensure that:

a) the planning of the quality management system is carried out in order to meet the requirements

given in 4.1, as well as the quality objectives;

b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order   to prevent their occurrence. Preventive actions shall be proportionate to the effects of the potential problems.

The organization shall document a procedure to describe requirements for:

a) determining potential nonconformities and their causes;

b) evaluating the need for action to prevent occurrence of nonconformities;

c) planning and documenting action needed and implementing such action, including, as  appropriate,

updating documentation;

d) verifying that the action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;

e) reviewing the effectiveness of the preventive action taken, as  appropriate.

Records of the results of any investigations and of action taken shall be maintained (see  4.2.5).